Stroke kills an American every four minutes – more than 525,000 individuals each year – and nearly 300,000 more fall victim to its debilitating consequences.

The onset of symptoms signal a dire emergency. According to the National Stroke Association, they can include:

Sudden numbness or weakness of the face, arm or leg, especially on one side of the body;

Sudden confusion, trouble speaking or understanding;

Sudden trouble seeing or blurred vision in one or both eyes; and/or

Sudden trouble walking, dizziness, loss of balance or coordination.

There are two types of stroke: hemorrhagic and ischemic. The first results from a ruptured blood vessel in the brain, and the other from an inadequate blood supply, usually due to a blood clot blocking an artery that feeds the brain.

The second variety, ischemic stroke, is by far the more common. Nearly nine out of 10 are of this type. And that's fortunate, because an ischemic stroke could be relatively easy to prevent – provided you see it coming.

If you had the technology to find and map arterial blockages safely, simply, and quickly, you could intervene with a relatively simple medical procedure, clear the blockage, and bring down that enormous annual incidence of stroke to a much smaller number.

Does such a technology exist?

Currently, doctors can use an ultrasound machine to detect the presence of an occlusion (blockage) or stenosis (narrowing) in a carotid or cerebral artery, but the patient then has to undergo a CT scan or MRI for more definitive information.

It's a complicated, drawn-out, and extremely expensive process, and you would think a single-step, cheaper technology might be a game changer – and represent a windfall for investors.

The device is about to enter pivotal clinical trials, and after they're completed, will go to the U.S. Food and Drug Administration (FDA) for marketing approval.

The CSS could save the government up to $34 billion a year, according to the CDC, and more importantly, hundreds of thousands of lives in the United States and around the world.

That's great news for patients and their families. And it has proven a terrific opportunity for investors, too. Since the company's IPO in November 2016, the stock is already up over 90%.

But here's the thing. This device may not be the silver bullet it's cracked up to be. And the stock isn't, either.

I'm going to show you what's really happening here and how to ultimately profit on this situation. It's a great example of how independent research can save you a lot of money in the long run…

Here's What Got Investors All Excited

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CVR Medical’s device is basically a sort of super-ultrasound machine that not only detects, but also maps stenosis or occlusion in the carotid artery, which runs up the neck to feed oxygen rich blood to the brain. As mentioned above, ultrasound is already used for this indication, but it needs to be done by a trained medical person, and it doesn’t give you a map—just a particular swooshing sound that will suggest you need a CT scan or MRI.

Recently, the company received approval from an Independent Review Board (IRB) for a clinical test at Thomas Jefferson University, one of several major medical schools in Philadelphia.

If eventually approved by the FDA, the CSS would represent a nice addition to the current spectrum of tools used in pre-stroke screening. The company is projecting U.S. sales alone to reach 400,000 devices annually, with a price tag of $49,000 per unit. That's a total U.S. market opportunity of $11.5 billion.

That's a gorgeous number, and I'd say it's wildly optimistic.

Because this device may not be the game changer it's predicted to be.

Here's why.

The company has identified primary care physicians as its major market. They would take the role of first-line screeners of patients at high risk for stroke, except that…

Ernie Tremblay has more than 25 years of experience in following and analyzing the latest developments in health, medicine, and related technologies. He understands the FDA approval process, as well as the "hard science" behind new, experimental drugs and the market demand for them - and has a comprehensive grasp of the complex dynamics that determine whether a new drug will be a breakthrough winner, or just another casualty of the FDA approval process.

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